{"id":14553,"date":"2023-08-30T00:45:00","date_gmt":"2023-08-29T16:45:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14553"},"modified":"2024-11-24T00:48:10","modified_gmt":"2024-11-23T16:48:10","slug":"roches-evrysdi-receives-ec-approval-for-expanded-indication-in-infants-with-sma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14553","title":{"rendered":"Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA"},"content":{"rendered":"\n

Swiss pharmaceutical giant Roche (SWX: ROG<\/a>) has received regulatory approval from the European Commission (EC) for an indication extension of its SMN2 splicing modifier Evrysdi (risdiplam). The drug is now approved for infants up to 2 months of age with a clinical diagnosis of spinal muscular atrophy (SMA) type 1, type 2, or type 3, or with one to four SMN2 copies. This approval is supported by interim clinical data showing that 100%, 67%, and 50% of participants achieved the milestones of sitting, standing, and walking after one year, with none requiring permanent ventilation.<\/p>\n\n\n\n

UK MHRA Approval for Tecentriq SC<\/strong>
Additionally, Roche announced approval by the UK\u2019s Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-L1-targeting monoclonal antibody (mAb) Tecentriq SC (atezolizumab) as a subcutaneous injection. The new formulation carries the same indications as the intravenous Tecentriq, covering certain types of lung, bladder, breast, and liver cancer. This more patient-friendly treatment option will now be covered by the National Health Service (NHS) England, expanding access for cancer patients.<\/p>\n\n\n\n

Implications for SMA and Cancer Treatments<\/strong>
The EC’s approval of Evrysdi for a broader patient population with SMA and the UK’s approval of Tecentriq SC mark significant advancements in the treatment landscape for these conditions. These approvals not only provide more treatment options but also align with the goal of improving patient outcomes and quality of life.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC)…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,107,18,68,15,24,163,939],"class_list":["post-14553","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-immunotherapy","tag-pd-1-l1","tag-pediatric-drugs","tag-product-approvals","tag-rare-orphan-disease-drugs","tag-roche","tag-swx-rop"],"yoast_head":"\nRoche's Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC) for an indication extension of its SMN2 splicing modifier Evrysdi (risdiplam). 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